一个Ib/II期的研究埃里布林与循环胺结合在患有晚期乳腺癌的患者
Ozge Gumusay1, Laura A Huppert2, Mark Jesus M Magbanua3
1Department of Medical Oncology, School of Medicine, Acibadem University, Istanbul, Turkey.
Breast cancer research and treatment
|October 10, 2023
概括
埃里布林加环胺组合在晚期乳腺癌患者中显示了79.5%的临床益处率. 这种EC疗法提供了一个有前途的治疗选择,具有可控的毒性,特别是中性衰竭.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 癌症治疗方法 癌症治疗方法
背景情况:
- 晚期乳腺癌 (ABC) 存在重大治疗挑战,特别是在严重预治疗的患者中.
- 新型组合疗法对于改善转移或不可切除的ABC的结果至关重要.
- 埃里布林和环胺是已确定的药物,但它们在ABC中的协同作用潜力需要进一步研究.
研究的目的:
- 评估埃里布林加环胺 (EC) 在晚期乳腺癌 (ABC) 患者的疗效和安全性.
- 确定临床益处率 (CBR) 作为主要终点.
- 评估二次终点,包括响应率 (RR),响应持续时间 (DOR),无进展生存期 (PFS) 和安全概况.
主要方法:
- 一个剂量升级研究,其次是转移或不可切除的ABC患者的剂量扩展队列 (N=44).
- 患者在第1天和第8天接受埃里布林 (1.4 mg/m2),在21天周期的第1天接受环胺 (600 mg/m2).
- 主要终点:临床益处率 (CBR). 二级终点:RR,DOR,PFS和安全性评估,包括不良事件和循环瘤细胞 (CTC).
主要成果:
- 总体CBR为79.5% (35/44),其中有7个部分反应和28例稳定疾病.
- 无进展生存 (PFS) 的中位数为16.4周 (95%CI:13.8-21.1周).
- 最常见的3/4级不良事件是中性质减退 (47.7%). 基线CTC患者的PFS中位数较短 (13.1 vs 30.6周).
结论:
- 埃里布林加环胺 (EC) 组合在重度预先治疗的ABC患者中显示出令人鼓舞的疗效,CBR为79.5%,PFS为16.4周.
- 该疗法一般耐受良好,中性质减退是主要的剂量限制性毒性.
- 该EC组合与单剂埃里布林相比较有利,因此需要进一步评估环胺的贡献.
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